EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

NCT ID: NCT02744651

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2021-12-31

Brief Summary

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

• Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

Detailed Description

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Conditions

Gastrointestinal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EUS-FNA

All patients with a confirmed suspicion of a submucosal tumor in the upper GI tract will be included in this study. A senior endoscopist will perform multiple passes of EUS-FNA until she/he has collected enough material for the pathologist to establish a possible diagnosis.

Group Type: ACTIVE_COMPARATOR

EUS-FNA

Intervention Type: DEVICE

Please note the text in section "Arm description"

EUS-Endodrill biopsy

All patients who are included in the study will also be examined by a senior endoscopist performing multiple EUS guided passes with the Endodrill biopsy. The harvested tissue from the tumor will be examined by a pathologist in order to establish a diagnosis.

Group Type: ACTIVE_COMPARATOR

EUS-Endodrill biopsy

Intervention Type: DEVICE

Please note the text in section "Arm description"

Interventions

EUS-FNA

Please note the text in section "Arm description"

Intervention Type: DEVICE

EUS-Endodrill biopsy

Please note the text in section "Arm description"

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

Exclusion Criteria

• Mental illness
• Extreme co-morbidity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Martin Jeremiasen

Consultant Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Johansson, SrConsultant

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Locations

University Hospital of Lund

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

Endodrill III

Identifier Type: -

Identifier Source: org_study_id